In the United States it is estimated that over 7 million women have infertility and another 3 million women intentionally get pregnant annually. An accurate yet convenient technology to monitor fertility is therefore desired.
Temperature measurement has been found effective to assist in monitoring fertility. Daily tracking of basal body (resting) temperature is an old technique that women use to help determine when they have ovulated, as a woman's basal body temperature usually rises between 0.2 and 0.6 degrees Fahrenheit around the day of ovulation. However, tracking basal body temperature is tedious because one must remember to take her temperature the very first thing in the morning, remember the measurement, and then record it onto her paper chart or into her fertility tracking software. The frustrating and time-consuming nature of this method deters more women from using it. Furthermore, it involves some interpretation of the temperature measurements to detect the rise indicative of ovulation, and some guessing as to when the subsequent fertile window is likely to occur.
Various approaches have been developed to chart temperature for fertility and to provide an interpretation of the BBT (Basal Body Temperature) measurements.
The “Lady Comp” (manufactured by Valley-Electronics GmbH, headquartered in Murau, Germany), for example, includes a thermometer attached by an electrical cord to a stand-alone computer. An example of a thermometer for measuring the temperature in low-convection media is described in U.S. Pat. No. 4,654,623.
More inventions have been created to provide some level of interpretation of these BBT readings. U.S. patent application Ser. No. 12/766,598 (Beth Rosenshein) and Ser. No. 12/890,743 (Witold Andrew ZIARNO et al) show methods for inserting a temperature sensor with wireless capability into bodily cavities, primarily the vagina, to monitor the temperature shift seen with ovulation. Recently published US20120238900A1 (Natalie Rechberg) and US20120265032A1 (Boaz Beeri) describe a portable preprogrammed thermometer for fertility status and an ovulating sensing and analyzing system respectively.
Patent Publication No. 2007/0282218 describes a method for measuring skin temperature using two temperature sensors separated by an insulating layer. The core body temperature is derived from a calculation in the difference between the sensors.
Patent Publication No. 2011/0301493 (Shamus Husheer, Cambridge GB) describes a method involving placing one sensor next to the body and another sensor in the same incasing at another depth, parallel to the lateral direction, and calculating the core body temperature off the difference in the temperature between sensors.
Patent Publication No. 2005/0245839 to BodyMedia (John Stivoric et al) describes a non-invasive temperature monitoring device using a skin sensor for continuous wear that similarly includes a skin temperature sensor and an additional ambient temperature sensor within the same housing.
U.S. Pat. No. 7,413,544 (Robert Kerr, II) describes another system and method for collecting and transmitting medical data. In one of the described embodiments, a measuring device is a fertility thermometer. Data is acquired by a remote system. A patient views here medical profile which might include temperature readings over the fertility cycle.
The method of combining temperature and the quality of cervical mucus wherein the quality of the cervical fluid is interpreted by the individual, known as the Sympto-thermal method, and has been known since the 1930s, and is highly accurate (98%) as a contraception method when practiced perfectly. However, a problem with the method is that it is tedious and somewhat subjective to determine the quality of the cervical fluid.
Various approaches have been developed to evaluate cervical mucus. For example, U.S. Pat. No. 4,685,471 (Jennie Regas and Ranjit S. Fernando) uses cervical mucus alone to predict ovulation. This approach is utilized in the OvaCue® fertility monitor to predict ovulation in a stand-alone device (manufactured by Fairhaven Health LLC, Bellingham, Wash.). Hormonal and biochemical changes that cause a variation in the electrolyte characteristics of cervical fluid are reflected in the electrical resistivity of a woman's saliva and cervical fluid (also known as vaginal fluid or mucus). Onset of ovulation is determined as a function of a peak resistivity measurement following the onset of menstruation, which peak is followed by a nadir and subsequent sharp increase in saliva electrical resistivity measurement.
Additionally, Patent Publication Nos. 2012265032 to Ben-David et al. and 2012238900 to Rechberg describe systems for collecting and transmitting medical data and determining fertility and ovulation.
U.S. Pat. No. 5,240,010 to Weinmann describes a device for monitoring temperature and changes in the characteristics of the cervical mucus (vaginally only) for evaluation in order to determine a women's fertile window. This device evaluates the measurements and provides feedback on the degree of fertility of the subject.
Notwithstanding the above, a need still exists for an improved clinical apparatus and method that monitors a woman's fertility, and one that is accurate and convenient for her to use regularly, particularly taking measurements orally that are reflective of hormonal and temperature changes associated with ovulation, and to make the information about her fertility status conveniently available to her throughout the day.